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FDA Takes New Steps to Curtail Youth Access to Tobacco Products and E-Cigarettes

  • The U.S. Food and Drug Administration (FDA) announced several new steps it is taking to combat youth access to tobacco products and e-cigarettes. In a March 4 statement, FDA Commissioner Scott Gottlieb, M.D., pointed out that retailers are on the frontlines of these efforts to reduce the health consequences of tobacco use and nicotine dependence and outlined the actions that the Agency is taking, beginning with ones directed at retailers.

  • First, FDA sent a letter to Walgreen Co.’s corporate management requesting a meeting to discuss the company’s policy on selling tobacco products to kids. Walgreens is currently the top violator among pharmacies that sell tobacco products, with 22% of the more than 6,350 stores inspected by FDA having illegally sold tobacco products to minors. (See our Feb. 8, 2019 blog for more information on previous action that FDA took against retailers, including Walgreens, selling tobacco products to minors.)

  • Second, FDA plans to also hold accountable 15 other national, corporate-owned chains and franchise stores with high rates of violations for illegal sales of tobacco products to minors. The agency will request information on what policies they have in place and what more they can commit to do to prevent youth tobacco sales. “Companies should be on notice that the FDA is considering additional enforcement avenues to address high rates of violations,” stated Dr. Gottlieb said in the statement, adding “Ignoring the law and then paying associated fines and penalties should not simply be viewed as a cost of doing business.”

  • With respect to retailers, Dr. Gottlieb added that FDA will continue to utilize its voluntary national retailer education program called “This is Our Watch,” which includes free resources designed to support retailers’ efforts to educate their staff on enforcing federal laws and regulations.

  • Third, on March 4, FDA sent its first warning letters to several companies for, among other things, selling electronic nicotine delivery system (ENDS) products and a waterpipe tobacco product with labeling and/or advertising that failed to include the required nicotine warning statement.

  • Fourth, FDA sent letters, also on March 4, to a number of governors across the country thanking them for their work to support efforts that led to the more than 81,570 warning letters that the Agency sent to retailers for violating the law, as well as the issuance of more than 19,800 civil money penalties and about 145 no-tobacco-sale orders for repeated violations since FDA began conducting tobacco retailer inspections in 2010.

  • Dr. Gottlieb concluded by stating, “We’ll continue vigorous enforcement activities, with a sustained campaign to monitor, penalize and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products.” He added that FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 64


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...